FDA Inspection
Stryker Medical Division of Stryker CorporationStryker Medical Division of Stryker Corporation – FDA Inspection, Nov 15, 2024
Record Details
This FDA Inspection record concerns Stryker Medical Division of Stryker Corporation, with an inspection on November 15, 2024, issued by the Detroit District Office, covering medical devices & rad health.
- Inspection Date
- November 15, 2024
- Product Type
- Medical Devices & Rad Health
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ID · 487bb4be-00dc-4503-a0fb-f5cc2744a0f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1255124
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
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Other FDA inspections of Stryker Medical Division of Stryker Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 13, 2016 | Not classified | Detroit District Office | |
| June 26, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 24, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 15, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Stryker Medical Division of Stryker Corporation
- FDA Inspection 1003139 - 2017-03-01
- FDA Inspection 996318 - 2016-10-13
- FDA Inspection 791490 - 2012-06-26
- FDA Inspection 682480 - 2010-09-24
- FDA Inspection 584103 - 2009-05-15
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